Phase I Study of the Clinical Pharmacology of Azithromycin in Buffy Coat of HIV-Infected Subjects.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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To compare the uptake of azithromycin in white cells relative to plasma concentrations in HIV-infected patients.

Detailed Description

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Patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.

Conditions

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Bacterial Infections HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Azithromycin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral agents, provided regimen has been stable for at least 1 month.

Patients must have:

* HIV infection.
* CD4 count \<= 200 cells/mm3.
* No active opportunistic infection (pending discussion with Pfizer Clinician).

Prior Medication:

Allowed:

* Prior antiretroviral agents.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active intercurrent illness (pending discussion with the Pfizer Clinician).
* Allergies to macrolide antibiotics.
* Signs and symptoms of severe illness that would preclude treatment.

Patients with the following prior conditions are excluded:

* History of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Clinically important change in baseline status within 4 weeks prior to study entry.
* Condition affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies) within 4 weeks prior to study entry.

Prior Medication:

Excluded:

* Investigational drugs including treatment IND drugs within 4 weeks prior to study entry.

Known drug or alcohol dependence.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Ctr for Phase I Research

Wichita, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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066-062

Identifier Type: -

Identifier Source: secondary_id

226D